Sanofi SA's Genzyme Announces Positive New Data from Two Phase 3 Studies for Oral Eliglustat Tartrate for Gaucher Disease

Sanofi SA's Genzyme announced positive new data from the Phase 3 ENGAGE and ENCORE studies of eliglustat tartrate, its investigational oral therapy for Gaucher disease type. Both studies met their primary efficacy endpoints and together will form the basis of Genzyme's registration package for eliglustat tartrate. In ENGAGE, a Phase 3 trial to evaluate the safety and efficacy of eliglustat tartrate in 40 treatment-naive patients with Gaucher disease type 1, improvements were observed across all primary and secondary efficacy endpoints over the 9-month study period. ENCORE, the second Phase 3 trial in the eliglustat tartrate development program, also met its primary efficacy endpoint. ENCORE is a multi-national, randomized, controlled, open-label, study designed to determine whether eliglustat tartrate is non-inferior to Cerezyme (imiglucerase for injection).